Treating Alcohol Withdrawal With Oral Baclofen

This study has been completed.
Sponsor:
Information provided by:
Essentia Health
ClinicalTrials.gov Identifier:
NCT00597701
First received: January 9, 2008
Last updated: July 25, 2011
Last verified: July 2011

January 9, 2008
July 25, 2011
April 2003
February 2008   (final data collection date for primary outcome measure)
Benzodiazepine Doses Used to Treat Acutely-withdrawing Alcoholic Patients in the Baclofen-treated and Placebo-treated Groups [ Time Frame: From eligibility for randomization (Clinical Institute Withdrawal Assessment [CIWA] score of at least 11) until 72 hours of observation had been completed. ] [ Designated as safety issue: Yes ]
In acutely-withdrawing alcoholic patients treated with either baclofen or placebo, symptom-driven benzodiazepine doses were assessed for the 72 hours following the first Clinical Institute Withdrawal Assessment (CIWA) score of 11 or greater.
Duration of alcohol withdrawal syndrome (AWS) as defined by duration of time from admission to study, to measurement of Clinical Institute Withdrawal Assessment for Withdrqwal for Alcohol (CIWA-Ar)<5. [ Time Frame: Duration of time from admission to study, to measurement of CIWA-Ar ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00597701 on ClinicalTrials.gov Archive Site
Not Provided
" Area under the curve" how much lower the CIWA-Ar scores are for the cases, compared to the controls (until the primary endpoint is reached). This endpoint will utilize the average CIWA-Ar scores in each of the nine 8 hour periods of the 72 hours study. [ Time Frame: Average CIWA-Ar scores in each of the nine 8 hour periods of the 72 hours study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Treating Alcohol Withdrawal With Oral Baclofen
Treating Alcohol Withdrawal With Oral Baclofen: a Randomized, Double Blind, Placebo Controlled Trial

The purpose of this study is determine if subjects with alcohol withdrawal who receive oral baclofen, plus standard benzodiazepine therapy, will experience less severe withdrawal symptoms than those who receive placebo plus standard benzodiazepine therapy.Subjects with alcohol withdrawal syndrome(AWS)who receive baclofen plus standard benzodiazepine therapy will experience fewer complications of AWS (as measured by use of additional sedatives, restraints, and/or intensive care unit [ICU] admissions) compared with subjects who receive placebo plus standard benzodiazepine therapy.

Alcohol use is ubiquitous in American society. 83% of Americans have ever consumed alcohol, 51% have in the lst month.

The average American consumes 2.18 gallons of ethanol yearly. Alcohol related morbidity and mortality are staggering problems in the USA. Symptoms of alcohol withdrawal occur because alcohol is a central nervous system depressant; abrupt withdrawal unmasks compensatory overactivity of certain parts of the nervous system, including sympathetic autonomic outflow. 5% of patients who undergo alcohol suffer from Delirium Tremors (DTs), a syndrome characterized by hallucinations, disorientation, tachycardia, hypertension, low grade fever, agitation, and diaphoresis.

DTs typically begin between 48-96 hours after the last drink and last 1 to 5 days. DTs requires hospitalization and vigorous activity in an ICU setting.

The most successful drug treatment for alcohol withdrawal has been found to be the benzodiazepines.

Symptom triggered treatment was found to be as effective as a fixed dose treatment to result in less drug being used overall, with a trend toward shorter duration of withdrawal treatment.

Baclofen is used orally for the treatment of spasticity resulting from multiple sclerosis, spinal cord injuries/diseases and intrathecally for spasticity related to cerebral palsy, spinal cord injury, and amyotrophic lateral sclerosis (ALS).

Its proposed benefit in alcohol withdrawal is that it may reduce voluntary alcohol intake, alcohol craving, and may suppress the intensity of alcohol withdrawal treatment.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Alcohol Withdrawal Delirium
  • Drug: Baclofen
    Baclofen 10 mg by mouth every 8 hours for 72 hours or until discharge if before 72 hours.
    Other Name: Lioresal
  • Drug: Placebo
    Placebo
  • Drug: Lorazepam
    Lorazepam was provided to all subjects (both arms of the study), as indicated by clinical condition. Standard "symptom-triggered dosing" of lorazepam for alcohol withdrawal was used. That is, the size and the frequency of the dose of lorazepam was determined by the severity of the alcohol withdrawal symptoms.
  • Active Comparator: Baclofen
    Standard benzodiazepine therapy plus baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
    Interventions:
    • Drug: Baclofen
    • Drug: Lorazepam
  • Placebo Comparator: Placebo
    Standard benzodiazepine therapy plus placebo every eight hous as inpatients for 72 hours or until discharge if less than 72 hours.
    Interventions:
    • Drug: Placebo
    • Drug: Lorazepam

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
79
February 2008
February 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Meet Diagnostic and Statistical Manual, 4th version, revised (DSMr-IV) criteria for alcohol withdrawal syndrome (AWS).
  • Be an inpatient at St. Mary's Medical Center (SMMC) or Miller Dwan Medical Center (MDMC) at time of study enrollment.
  • Have an alcohol withdrawal score as measured by standard SMMC or MDMC inpatient protocol sufficient to trigger the use of benzodiazepine withdrawal therapy.
  • Agree to abstain for alcohol for duration of study.
  • Be able to provide informed consent.

Exclusion Criteria:

  • The patient must not have any other active drug dependence in addition to alcohol.
  • Be unwilling or unable to forgo alcohol for the duration of the study.
  • Be using baclofen at the time of study enrollment.
  • Be using benzodiazepines for any reason other than acute alcohol withdrawal syndrome at time of study enrollment.
  • have known baclofen or benzodiazepine sensitivity.
  • Be unable to take oral (PO) meds.
  • Be unable to complete one of two consenting procedures.
  • Be pregnant or breastfeeding.
  • Have a serum creatine level > 2.0.
  • Have a history of non alcoholic withdrawal seizures.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00597701
090403
No
Jeffrey Lyon, MD, Essentia Health
Essentia Health
Not Provided
Principal Investigator: Jeffrey Lyon, MD Essentia Health
Essentia Health
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP